Science thomsonreuters.com

Victor Camlek is the director of Market Intelligence and Market Research. In this role Victor is responsible for monitoring, assessing, alerting and advising senior management about the issues, impacts and opportunities affecting all our scientific markets.

With over 25 years experience in the industry, Victor has led market intelligence teams and served as a principal market intelligence analyst focused on the telecommunications industry for Telcordia Technologies.  He led a team of senior market intelligence analysts who provided information based consulting services for the telecommunications carriers and internal clients.  Prior to his 17 years at Telcordia, Victor worked as an information professional in the healthcare and engineering industries.

Currently Network Chair for the SLA CI Division responsible for implementing a mentoring program, Victor is also a candidate for the Chair Elect for the Division and has written a number of articles published in the Bulletin of the SLA Competitive Intelligence Division. In addition he is a member of the NFAIS 2009 conference planning committee.

Victor has a Masters in Library Science from Queens College of the City University of New York and a BA in communications from Hunter College of the City University of NY.

Presentations & Conferences

• The Making of A CI Professional: The SLA Division Competitive Intelligence Mentoring Program | SLA Annual Conference | Seattle, June 2008
• The New Information Economy: The Changing Landscape | NFAIS Annual Conference | Philadelphia, February 2008
• Collaboration and Productivity Tools: A Survey of Knowledge Workers | Online | London, December 2007
• Competitive Intelligence in the Age of Google | Online | London, December 2006
• Market Research: Anticipating and Monitoring User Needs | SLA Annual Conference | Toronto, June 2005

In his current role Mark Markley supports the intellectual property portfolio including Aureka, MicroPatent, and Thomson Innovation. He focuses on increasing the visibility of patent solutions and supporting the current subscriber base.

He has been involved in patent information for over 14 years and is a member of PIUG.

Following graduate school in microbiology and molecular biology Mark worked for patent law firms in Washington DC. He joined Thomson Reuters with the acquisition of Derwent and has held various training and sales roles. He has also worked for STN/Fiz-Karlsruhe as regional sales manager and at LexisNexis as an intellectual property specialist.

Product Expertise

• Aureka
• Thomson Innovation
• Thomson Data Analyzer

Presentations & Conferences

• Thomson Innovation | ACS Spring Conference | New Orleans, April 2008

Donald Walter joined the company over 15 years ago. His primary responsibility is to train users on our scientific and healthcare solutions, specializing in chemical and patent information. He also conducts searches and analyses for legal and industrial clients, with a special emphasis on pharmaceutical and chemical subjects.

He learned his craft at Exxon Research and Engineering, conducting patent and scientific literature searching for clients in the legal and technical departments.

With over 28 years experience in the patent industry and a Ph.D. in Chemistry from Yale, Don is a member of the Patent Information User Group and the American Chemical Society.

Product Expertise

• GENESEQ
• DWPI
• Thomson Innovation
• Thomson Pharma
• Web of Knowledge/Web of Science

Presentations & Conferences

• Are There Hallmarks of Important Patents? | Patent Information Expo 2008 | November 11-12, 2008

Bob Stembridge has 25 years experience working within the patent information industry and in his current role is responsible for liaison with customer user groups on behalf of the organization.

He is currently Chair of Patent and Trade Mark Group and has published articles on research and innovation process, patent analysis, patent portfolio management and IPC reform. Bob is also an affiliate member of the Chartered Institute of Library and Information Professionals and a full member of the American Chemical Society. He presents regularly at information conferences and events.

Bob graduated from University of Sussex with a BSc in Chemistry. He joined Thomson Scientific in 1980 and has held various roles in editorial, marketing, sales and product development. Leaving in 1988 for interludes working as Information Analyst specialising in patent analytics at British Petroleum and uropean Sales Liaison with Dialog, he returned to Thomson Reuters in 1996.

Presentations & Conferences

• Thomson Innovation – The New Standard in IP Research and Analysis | IPI-ConfEx - Barcelona, March 2008 | PIUG - Arlington, May 2008 | SLA - Seattle, June 2008
• Never Mind the Quality, Feel the Width | EPO Information Conference | Stockholm, October 2008

Rob Willows is Vice President, Patent Offices and Special Accounts. He manages business relationships with Patent and Trademark Offices worldwide, with a special focus on delivering customized patent information solutions that enhance the processes of prior art search and examination within these offices.

Rob has been responsible for successful in-house loads of our data, including the World Patents Index database, at EPO, USPTO, JPO and the Chinese Patent Office. He meets regularly with senior officials of all the major patent offices for strategic discussions on key issues relating to Intellectual Property.

With over 35 years experience in the field of patent and Scitech information, Rob is a regular speaker at major international IP conferences, including EPIDOS and EAPIC. He is also a member of the Coalition for Patent and Trademark Information Dissemination and PatCom (The Patent Committee).

Product Expertise

• GENESEQ
• DWPI
• Thomson Innovation

Presentations & Conferences

• Using IP Information to Enhance Business Returns and Shareholder Value | Intellectual Property Strategy Forum 2.0 | Syndey, February 2008

Shannon Bennett is a member of the Thomson Reuters API Intelligence team. In addition to collecting and validating intelligence contained in the Newport product suite, she is following closely developments in the Indian API and finished dose markets and has written and presented on that topic.

Prior to joining Thomson Reuters in 2009, Shannon was the Regulatory Affairs and Marketing Coordinator at Putney, Inc., a specialty veterinary drug company. Shannon holds a degree in journalism from University of New Hampshire.

Publications, Presentations & Conferences

• The Falsified Medicines Directive: Impacts on API imports | Speciality Chemicals Magazine | June 2013
• Is API manufacturing returning to Europe PDF | June 2012
• China's Growing Presence in the Global Supply Chain PDF | Chemistry Today | February 2012
• Examining India's Focus on APIs & Increasing Opportunities | API Global Sourcing Strategies | Berlin, June 2010
• The Rise of India | Chemistry Today | May 2010

Andrew F Bourgoin is a Pharmaceutical Research Analyst at Thomson Reuters. In addition to collecting and validating the intelligence contained in the Newport product suite, Andrew actively tracks developments within the global biologic pharmaceutical landscape. Prior to joining Thomson Reuters, Andrew was a graduate student at the Muskie School for Public Service where he received a master degree in public policy and management.

Publications, Presentations & Conferences

• Defining valuable information in a shifting industry | Journal of Commercial Biotechnology | April 2013
• With Biosimilars: Stick to Your Strengths | CHEManager | September 25, 2012
• Presentation on Biosimilars PDF | New York Pharma Forum | January 31st, 2012
• Competition Heats Up in the Biologics Market | Pharma Magazine | July/August 2011
• What You Need to Know About the Follow-On Biologics Marketing in the U.S.: Implications, Strategies and Impact PDF | Thomson Reuters White Paper | January 2011
• The US Follow-on Biologic Market- Developments, Trends and Strategies PDF | Thomson Reuters Webinar | February 2010
• Thriving Generics — Patent Cliff Revenues Fertilize Generics Companies PDF | CHEManager Europe | No. 9/2012

In her current role, Molly is responsible for overseeing the collection and validation of competitive API intelligence contained in the Newport product suite. Newport's research team specializes in gathering competitive intelligence on the worldwide active ingredients market and global generic pharmaceutical sector. Prior to joining Thomson Reuters in 2007, Molly worked in the environmental field as a project coordinator and quality assurance officer. She holds a degree in chemistry from Smith College, and performed graduate studies at the SUNY College of Environmental Science and Forestry.

Publications, Presentations & Conferences

• Will API Manufacturing Move out of India and China? PDF | CHEManager Europe | April 2012
• Current & Future Sourcing Trends: Is India and China the only future for API sourcing? PDF | CPhI Worldwide | Frankfurt, October 2011
• API Sourcing in China and India: Is Asia the Only Option for the Future? PDF | CHEManager Europe | October 2011
• Active Ingredient Sourcing Trends: analyzing the shift from traditional sourcing markets and their potential resurgence PDF | Chemistry Today | July/August 2011
• Interview with Mike Rice: Russia intends to make the drugs that it needs PDF | Generics Bulletin | April 8, 2011
• Russia: Effects of government involvement in creating pharma strategy PDF | PharmaSource | Berlin, March 24, 2011
• Geo-Sourcing Trends 2011: Analysing the latest sourcing trends and pharmerging markets PDF | PharmaSource | Berlin, March 23, 2011

Benjamin Burck is responsible for the Paragraph IV patent challenge coverage that appears in Thomson Reuters Newport products. Ben joined Thomson Reuters in 2005 as an analyst on the Newport API intelligence team, gathering and validating competitive intelligence on the worldwide active ingredients market.

Before joining Newport, Ben spent eight years documenting diagnostics devices and laboratory automation for Bayer HealthCare. He previously had a career as a research and academic librarian, first at the Research Libraries of the New York Public Library and later at the University of Pennsylvania. Ben has a BA from Northwestern University and a Master's degree from Indiana University.

Publications, Presentations & Conferences

• First to File and Beyond: Paragraph IV Business Strategies PDF | Webinar | March 2012
• Preparing for Paragraph IV Patent Challenges PDF | Webinar | February 2011
• Paragraph IV Watch (series produced in collaboration with the editors of Generics Bulletin)
  • Acetadote cases may hinge on excipient PDF | Generics Bulletin | 13 July 2012
  • Par holds pole position for colchicine PDF | Generics Bulletin | 8 June 2012
  • Bystolic lacks barriers to block filings PDF | Generics Bulletin | 20 April 2012
  • Fusilev could offer an attractive niche PDF | Generics Bulletin | 9 March 2012
  • Lysteda differs in a lack of FDA listing PDF | Generics Bulletin | 3 February 2012
  • Patanase presents a unique challenge PDF | Generics Bulletin | 1 November 2011
  • Nuedexta comes under instant attack PDF | Generics Bulletin | 3 October 2011
  • Roxane challenges Jazz' Xyrem listings PDF | Generics Bulletin | 5 August 2011
  • Desonate disclosure could prove costly PDF | Generics Bulletin | 10 June 2011
  • Dexilant depicts drama of US first-to-file PDF | Generics Bulletin | 6 May 2011
  • Lotronex challenge raises timing issues PDF | Generics Bulletin | 4 March 2011
  • Firms are awake to Silenor opportunity PDF | Generics Bulletin | 1 February 2011
  • Zydus tries novel strategy on Strattera PDF | Generics Bulletin | 3 December 2010
  • Challengers eye bimatoprost patents PDF | Generics Bulletin | 15 October 2010
  • Ezetimibe attracts additional interest PDF | Generics Bulletin | 17 September 2010
  • Companies pick their paths on Trilipix PDF | Generics Bulletin | 16 July 2010
  • Filings for Vanos rivals remain topical PDF | Generics Bulletin | 30 June 2010
  • Intuniv shows the value of exclusivity PDF | Generics Bulletin | 28 May 2010
  • Sandoz aims to call the tune on Lyrica PDF | Generics Bulletin | 23 April 2010
  • Paddock and Perrigo pursue Clobex PDF | Generics Bulletin | 26 March 2010

Mike Chace-Ortiz is responsible for identifying transformational growth opportunities for the Life Science business, focusing on late-stage development, regulatory, post-approval and generics areas.

Previously, as Director of Product Strategy, he managed the long-term development of our products and services for generic companies and innovators. He joined Thomson Reuters (then Newport Strategies) in 2003 and has held a number of roles within the company including the Custom Solutions Team, product specialist and new business development Director.

With 20 years in life sciences, Mike has experience of the generic pharmaceuticals industry, APIs, innovator discovery, research, pre-clinical and clinical development, regulatory and commercial processes as well as pharmaceutical information systems. Previously, Mike was a Managing Consultant with PA Consulting Group's Life Science & Technology practice in Cambridge, MA. He has also held management positions in the Life Science practices of Barnett International/PAREXEL and with Deloitte Consulting in Philadelphia, and Bath, UK.

He obtained a Master of Engineering in Electronics, is a member of the Institute of Electrical Engineers, a Chartered Engineer and in 1985 received the Telecom Equipment Manufacturer's Association (TEMA) Award for Excellence in R&D.

• Generic Intelligence & Newport

Presentations & Conferences

• Second Wave of Emerging Markets PDF | PHARMASOURCE | Munchen, March 2010
• Deals Megatrends Part II PDF | PHARMASOURCE | Munchen, March 2010
• The Future of Deals in the Generic Industry PDF | DCAT | New York, March 2010
• Pharma Sourcing from India and China PDF | PHARMASOURCE | Berlin, March 2009
• Blurring of the Lines: Is Innovator and Generic Becoming Harder to Discern? PPT | DCAT | New York, March 2008
• The Role of API Intelligence in Generic Product Development | CPhI China | Shanghai, June 2007
• Tools and Trends for Generic Product Selection | CPhI Japan | Tokyo, April 2007
• Generic Business Development Tools | CPhI Worldwide | Paris | November 2006
• API: The Secret Ingredient in Specialty Portfolios | CBI Specialty Pharmaceutical Conference | Philadelphia, 2003
  

David Harding joined Thomson Reuters in 2005 as a member of Newport's research team which specializes in gathering competitive intelligence on the worldwide active ingredients market and the generic pharmaceutical sector.

In 2007, Dave took an additional role, travelling worldwide, to support the Thomson Reuters global sales force, with the sales of Newport Vision and Newport Horizon. He twice received recognition for this work with the Thomson Scientific Outstanding Contribution to Business Award.

Since 2010 Dave has been leading a team of other Solution Specialists in providing value driven technical sales presentations to clients worldwide about the content, technology, and services that Thomson Reuters Life Science can offer. 

Dave earned his BS in Economics with Business minor from the University of Utah.

Product Expertise

• Generic Intelligence & Newport

Presentations & Conferences

• Succeeding in a Rapidly Evolving Global Generic Drug Industry | CPhI Germany | Frankfurt, October 2011
• Analyzing the Latest Sourcing Trends and Finding Quality API Sources | Abu Dhabi, May 2011
• How M&A Activity is Shaping the Future of the Industry and Your Business PDF | DCAT | New York, March 2010
• How Originators Can Improve Their Understanding of Generic Competition PDF | CPhI Spain | Madrid, October 2009
• Identifying And Exploiting API Opportunities Across Emerging Markets PPT | Berlin, Germany , November 2008
• Product Selection for API Manufacturers and Generic Pharmaceutical Companies: A Tool for Success PPT | CPhI China, Shanghai | June 2008
• Perceptions vs. Reality, Facts and Figures on the Generic Industry PPT | DCAT Week - New York, March 2008 | CPA Event - Italy, May 2008
• Critical Success Factors for the Korean Generic and API Industry in a post FTA Environment PPT | KDRA event, South Korea | June 2007

Michael Glessner is a Pharmaceutical Research Analyst for Thomson Reuters.  In addition to collecting and validating the intelligence contained in the Newport product site, Michael actively tracks developments in the Japanese generic drugs market.

Prior to joining Thomson Reuters, Michael worked as a Senior Clinical Research Scientist with AstraZeneca Pharmaceuticals.  Michael has a B.S. in Biology from Wake Forest University and a Masters in Ecology and Environmental Science from the University of Maine.

Publications, Presentations & Conferences

• A Smart Target for Generics? | CHEManager Europe | No. 11/2012
• Wading through Japan  | Express Pharma | 10/2012

Bob Kennedy is the Manager of Industry Research and is responsible for overseeing the activities of the Thomson Reuters API Intelligence team who collect and validate the competitive API intelligence that is contained in the Newport product suite.

Prior to joining Thomson in 2007, Bob was a QA consultant for Synta Pharmaceuticals. He also held roles as both a scientist and a QA auditor during his six year term at XenoTech LLC, a company specializing in non-clinical drug metabolism and drug-drug interaction studies. Bob holds a master's degree in biology from Western Illinois University.

Product Expertise

• Generic Intelligence & Newport

Publications, Presentations & Conferences

• China increases its actvity in regulated markets PDF | Pharma China | July 2012
• China's Changing Role in the Global Pharmaceutical Supply Chain PDF | Pharma China Seminar | Princeton, New Jersey, May 2012
• Sourcing beyond India and China | C&EN | February 2012
• GDUFA: Who Will Benefit? | CHEManager Europe | January 2012
• Current & Future Sourcing Trends: Is India and China the only future for API sourcing? PDF | CPhI Worldwide | Frankfurt, October 2011
• China takes action on image PDF | Specialty Chemicals Magazine | August 2011
• Survival of the Fittest PDF | Specialty Chemicals Magazine | June 2010
• Can China Retain its API Sourcing Appeal? PDF | Scrip 100 | December 2009
• For How Long Will the Chinese API Sourcing Market Retain Its Appeal? PDF | API Global Sourcing Strategies | Berlin, June 2009
• China's Changing Role in the Global Pharmaceutical Supply Chain | Scrip Online | January 29, 2009

Emily is a Pharmaceutical Research Analyst within the API intelligence team. In addition to collecting and validating intelligence contained in the Newport product suite, she is following developments in the Chinese API and finished dose markets. Additionally, Emily tracks developments within the global antibiotics and antivirals market. Emily holds a degree in biology from the University of Maine.

Publications, Presentations & Conferences

• Antibiotics — Will Changes to Eastern Regulations Impact the West? PDF | CHEManager Europe | No. 6/2012

As the Senior Director of Generics and Content Strategy, Kate Kuhrt oversees Thomson Reuters research efforts regarding the generic and active ingredient industries and collaborates with teams across Thomson Reuters on content creation and acquisition opportunities.

Kate joined Thomson Reuters with the acquisition of Newport Strategies in 2004. She has published a number of articles discussing the challenges and opportunities facing the generics and API industries in different parts of the world and has presented at numerous conferences.

Prior to joining Newport Strategies in 2002, Kate was an Associate at the Pharmaceuticals division of CRA International, a business and litigation consulting firm headquartered in Boston. Kate graduated from Bowdoin College in Brunswick, Maine summa cum laude with a dual major in Economics and Government & Legal Studies.

Product Expertise

• Generic Intelligence & Newport

Publications, Presentations & Conferences

• Trends in Pharmaceutical Outsourcing | CHEManager Europe | July 19, 2012
• Interview with Patricia Van Arnum: The Changing Players and Supply Base for Generic Drugs | Pharmaceutical Technology Sourcing and Management | April 6, 2011
• Approaching the patent cliff: how did we get here and what comes next PDF | DCAT, March 2011
• Interview with Mike Rice: India and China forge ahead while Europe plays catch-up PDF | Generics Bulletin | February 1, 2011
• Downward Trends in Traditional Sourcing Markets and the Rise of Pharmerging Markets PPT | CPhI Virtual Experience Day | October 27, 2010
• Emerging Market API Demand Opportunities PDF | CPhI Spain | Madrid, October 2009
• Opportunities to Sell APIs from Regulated Markets into India and China PDF | SCRIP, May 2009
• Generic Drug Industry Outlook (video) | New York, NY, March 2009
• Identifying Commercial Opportunities to Sell API to Emerging Markets PDF | DCAT Week | New York, March 2009
• The BRIC Countries: Opportunities for Regulated Market Players Pharmaceutical Technology | August 1, 2008
• Emerging Markets as Opportunities, Rather than Threats PPT | DCAT Week | New York, March 2008
• Generic Drugmakers Eye New Opportunities in Japan PDF | Thomson Financial News | April 7, 2008
• Tools and Strategies for Launching a Successful Generic in Today's Ultra Competitive Environment PPT | European Generic Medicines Congress | Berlin, Germany, September 2007
• Tools and Trends in Generic Product Selection PPT | CPhI China | Shanghai, June 2007
• Responding to the Challenges Facing the Generics Industry PDF | Industrial Pharmacy | September 2006
• Threats and Opportunities for the Generic APIs Industry PDF | SP2 | September 2006
• Threats and Opportunities for the Generic Industry PPT | APIs Europe | Italy, June 2006

Meg Egan Auderset is a medical/regulatory writer for Thomson Reuters. She holds an MS degree in Magazine Journalism from the Newhouse School of Public Communications at Syracuse University in New York, and an MSW from the School of Social Administration at Temple University in Philadelphia, Pennsylvania. Ms. Egan Auderset is a writer and editor with more than 20 years of work experience in the US and Western Europe. She has reported, written and edited in a variety of settings and on a wide range of projects, including news articles, magazine features and press releases related to healthcare, social welfare, and legal issues. She has also written on topics related to FDA drug-approval processes and Medicare coding and reimbursement issues.

JCS Articles

• Listen to Us: Patient Impact on the Drug Approval Process PDF | December 2012
• Generics Bid the User Fee-Free Era Farewell | November 2012
• Stronger Rules Proposed to Protect Subjects in Clinical Trials | September 2011
• Focusing Risk Management Strategies: The Use of Medication Guides | May 2011

Global Forum

• How Cambodian Sex Workers Helped Change the Rules for Community Engagement | April 2013
• Japan's Efforts to Keep Innovative Research on Japanese Soil | October 2012
• Speaking Up in Japan | October 2012

Gina Ballinger is Senior Manager of Regulatory Intelligence and is responsible for managing the U.S. regulatory writing team, and researching new products and enhancements in the areas of pharmaceutical and biotechnology regulatory affairs. She also writes regulatory summary documents for the IDRAC database on all US regulations pertaining to drugs, biologics, and medical devices.

With over 20 years of experience in healthcare and over 9 years in regulatory affairs, Gina has published a number of articles in professional journals, and online on topics related to the drug development. She is a member of the Regulatory Affairs Professional Society, the Drug Information Association and the Food, Drug and Law Institute, as well as a member of Sigma Theta Tau, International Honor Society of Nursing.

Gina is a graduate the University of Maryland with a Bachelor of Arts from the College of Behavioral and Social Science and Bachelor of Science in nursing. She has attended continuing education courses at the Johns Hopkins University, School of Public Health in Baltimore, Maryland, and is pursuing a graduate degree at the University of Maryland in healthcare administration with a policy focus.

She has worked previously as a licensed nurse in direct patient care and as a medical writer in pharmaceutical regulatory affairs.

Regulatory Focus

• Autumn 2012: to submit an article based on a session attended at the 2012 RAPS conference

JCS Articles

• Expanding Access to Treatments Through FDA's NSURE Proposal | March 2013
• New Guidances Offer Insight to Biosimilarity in the US | March 2012
• FDA's Efforts on Improving Access to Therapies for Rare Diseases | March 2011
• FDA Guidance on Investigator Responsibilities for Protecting Study Subjects in Clinical Trials | March 2010
• Protecting Human Subjects in Clinical Trials: The FDA Bioresearch Monitoring Program PDF | May 2009

EPC Articles

• The Heart of the Matter | Summer 2012
• Weighing Up the Decision | Summer 2011

Walter Chalkley is a senior editorial project manager for IDRAC and the current project manager for the AdComm Bulletin. Mr. Chalkley's education was completed primarily at Virginia Commonwealth University in Richmond, Virginia where he received degrees in English, History and Philosophy. He has written and edited professionally for more than 15 years.  Mr. Chalkley achieved his Regulatory Affairs Certification (RAC) in 2006 and his regulatory interests include pathways to approval of biologic products with emphasis on vaccine development. He has attended and reported on nearly 150 advisory committee and FDA sponsored meetings, reported on industry-wide meetings, and has had articles published on clinical development regulatory issues.

Regulatory Focus

• Autumn 2012: to submit an article based on a session attended at the 2012 RAPS conference

JCS Articles

• The Slow Move to Quadrivalent Influenza Vaccines | May 2012
• The Collaborative Opportunities for Research Excellence (CORE) Programme Supports Nanotechnology Studies | July 2011
• FDA's Proposed Rule: Reporting Information Regarding Falsification of Data | November 2010
• The FDA-EMEA Good Clinical Practice Initiative | November 2009

Deborah Komlos is currently the Senior Medical & Regulatory Writer for Thomson Reuters. In this capacity, she reports on trends pertaining to drug and biologic products under review by the US Food and Drug Administration, and manages editorial projects. Ms. Komlos was educated in Canada and holds post-baccalaureate degrees in botany and journalism and has more than 12 years of professional writing and editing experience. Her writing has been recognized by the Kenneth R. Wilson Awards for Canadian business journalism. For more than a decade, Ms. Komlos was the editor-in-chief of Sanctuary, the official newsletter of the Ontario Chapter of Sierra Club Canada. Ms. Komlos has managed several regulatory affairs projects for IDRAC including a regulatory affairs newsletter and IDRAC's AdComm Profiles.

SPECIALTY CHEMICALS MAGAZINE

• Evolving Approaches to Developing Quality Pharmaceuticals | April 2013

JCS Articles

• New Incentives for Antibiotic Development | January 2013
• Improving Clinical Studies in Women | January 2012
• Editorial Advisors Keynote | July 2011
• Revised Safety Reporting Regulations for Drugs and Biologics and Bioavailability and Bioequivalence Studies | January 2011
• Adaptive Design Clinical Studies for Human Drugs and Biological Products | July 2010
• Current Good Manufacturing Practice for Phase I Clinical Trial Products PDF | July 2009

Global Forum Articles

• Guiding Strategic Data Collection in Product Development PDF | June 2012

Anne Lecocq is Senior Manager of Regulatory Intelligence and is responsible for European information. She manages the IDRAC South EU, North EU, Eastern EU and South Eastern EU teams covering 37 countries including Russia and International.

Anne has 8 years of experience in regulatory affairs. She joined Thomson Reuters in 2008 and has actively contributed to the creation of new content and enhancements on EU information. She worked on a Pediatric project to facilitate the access to Pediatric development information in Europe and recently provides analysis tools to facilitate understanding and follow-up of new Pharmacovigilance legislation.

Anne is a chemist with a master's degree in Regulatory Affairs. She has worked for the pharmaceutical industry in Regulatory Affairs including for a generic company where she performed audits on the quality section of application dossiers.

Larry Liberti has worked in and with the pharmaceutical industry, in the fields of pharmaceutical and clinical research and development for 35 years. While at Wyeth Laboratories he served in Product Development, Clinical R&D, and Medical Affairs. He served as Editorial Director, North America, for ADIS International before starting Pharmaceutical Information Associates (PIA) a company specializing in regulatory writing and regulatory consulting. He was a co-founder of Astrolabe Analytica under which he helped develop and commercialize the Astrolabe Message Mapping System. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd; formerly the CMR International Institute for Regulatory Science), an independent division of the IP and Science business of Thomson Reuters.

Larry is a pharmacist with a master's degree in pharmacognosy from the Philadelphia College of Pharmacy and Science. Mr Liberti has been actively involved in promulgating best practices in the regulatory aspects of medicines development, especially in the emerging markets. He lectures on regulatory issues concerning expediting patient access to medicines, new paradigms of drug development and ways to improve communications between regulators, HTAs and sponsors.

He is currently undertaking paralegal certification. He was awarded the status of Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society. He is a Fellow of the American Medical Writers Association and is a recipient of their Golden Apple award for excellence in teaching.

Product Expertise

• CMR International Institute for Regulatory Science

Presentations & Conferences

• Monitoring the Value of Trial Registration Information | July 16, 2008
• Choosing the Appropriate Medium for Your Publication: Journal Selection Tactics | The International Publication Planning Association (TIPPA) Annual Conference | San Francisco, June 2008
  

Laetitia is a Project Manager in Regulatory Intelligence and is responsible for managing the IDRAC South Eastern EU team which includes in addition Ireland and Switzerland information. Laetitia actively participates in the development of new regulatory contents such as an added value document providing an EU Medicinal Products Registration Overview and is coordinating the development and the maintenance of IDRAC EU Comparative Tables.

Laetitia has over 6 years of experience in Regulatory Affairs. Before joining Thomson Reuters in 2012, she worked as a Regulatory Affairs Specialist in the Pharmaceutical Industry where she was in charge of various European applications as well as national applications in EMEA and APAC countries (for drugs and medical devices). She was involved from the development, Marketing Authorization Application submissions until the maintenance.

She is used to working in an international environment. She has also done a 6-month internship in an international pharmaceutical company in Switzerland.

Laetitia is a pharmacist and studied at the University of Paris XI University, Châtenay-Malabry, France. She holds a Master of International Drug Development and Registration. Her thesis was on the physiopathology of ototoxicity, pharmaco-economic study and interest to develop a preventive treatment containing leupeptin.

Publications

• DIA Euro-Meeting, Vienna (March 2007 in Vienna) poster presenter | Regulation on medical devices: the European Union versus the United States| L. Meidine and D. Chan, Faculty of Pharmacy, Paris-XI University, France

Rosanna Melchior joined Thomson Reuters in 2002. She is responsible for the e-learning regulatory educational offer (Regulatory Online Learning), the Global Module (aka Global Regulatory Comparison in Cortellis) and oversees the Rest of the World (ROW) team responsible for the regulatory intelligence in Canada, the Asia Pacific and Middle East Africa regions.

She is a registered pharmacist from the University of Padua (Italy) and holds a Master Degree in Regulatory Affairs from Paris XI University (France).

Rosanna will be presenting at the DIA's webinar:

Certificates of Pharmaceutical Products (CPP) for Regulatory Submissions
May 23, 2013 • 10:00AM.

This session will discuss:

• Format and Content of Certificates of Pharmaceutical Products (CPP)
• Legalization of CPP
• Country of Origin
• Planning submissions requiring CPP (first registrations/post-approval changes)
• CPP versus Free Sales Certificates

Find more information here

She has made several interventions at international conferences:

Conferences

• 48th Annual DIA Meeting (June 24-28, 2012 in Philadelphia, PA), poster presenter ‘Implementation status of CTD, eCTD and paper-free applications: a global overview.’ PDF | June 2012
• 47th Annual DIA Meeting (June 19-23, 2011 in Chicago, IL) speaker on ‘How Transparent are Regulatory Agencies with regard to Review Timelines? A Global Review.’ PDF | June 2011
• 13th Applied Clinical Trials Meeting (October 2006 in Amsterdam, Netherlands), keynote speaker on ‘The emergence of Compassionate Use’ PDF | October 2006
• 18th DIA EuroMeeting (March 2006 in Paris, France), speaker on ‘Compassionate Use Programmes in North America, Australia and Europe: Overview of Authorities and Sponsor’s Roles and Responsibilities’ PDF | March 2006

Publications

• A Time for Compassion. What Canada, the EU, and United States are doing to update their compassionate use regulations, Applied Clinical Trials Magazine, Sep 1, 2007
• E-Train to Retain, Pharmaceutica Executive Europe, Nov 1, 2006 PDF | November 2007

Alejandra Muntañola is Senior Manager of Regulatory Intelligence and is responsible for managing the IDRAC U.S. and Latinamerica regulatory teams. Alejandra has over 11 years of experience in regulatory affairs. She joined Thomson Reuters in 2005 and has actively contributed to the creation of new content and enhancements on US regulations pertaining to drugs, biologics, and medical devicesfor IDRAC. Alejandra has published a number of articles in the Journal of Clinical Studies, related to clinical development regulatory issues.
Alejandra is a pharmacist from Complutense University, Madrid, with a master's degree in European Regulatory Affairs. She has worked for the pharmaceutical industry in Regulatory Affairs. She is a member of the Drug Information Association.

JCS Articles

• The FDA Underscores the Importance of Retention of Research Data PDF | September 2009
• Informed Consent Elements | September 2010
• Companion Diagnostics | December 2011
• FDA Expands Rules on the Disqualification of Clinical Investigators | September 2012
• 47th Annual DIA Meeting, (19-23 June, 2011 in Chicago) poster presenter | Year REMS Analysis for FDA-Approved Drugs and Biologics with a Comparison of US-REMS vs EU-RMP | June 2011

Céline Rodier is Managing Editor in Regulatory Intelligence and is responsible for managing the IDRAC North EU regulatory team covering 7 countries including the United Kingdom. Céline has 13 years of experience in the pharmaceutical sector, including over 5 years in regulatory affairs. She joined Thomson Reuters in 2010 and has actively contributed to improve quality of the modules she is responsible for. She is also involved in the development of new regulatory content related to the European regulatory framework. 

Céline is a Pharmacist from Université Claude Bernard, Lyon I (France). She continued on at Faculté de Pharmacie de l'Université de Limoges (France) for an additional 4 years to specialize in Industrial Pharmacy and Biomedicine, where she had the opportunity to work in hospital pharmacy (drug and medical devices), clinical research center, laboratory of human nutrition and radiopharmaceutical industry. Her thesis was on Pharmaceutical Advertising - legal environment, control by health authorities and organization in a pharmaceutical company. She then took a position as Regulatory Affairs Pharmacist in Laboratoires Cyclopharma (radiopharmaceutics), where she was in charge of various national and European applications (for drugs, medical devices and facilities), advertising control, pharmacists' registration, setting electronic submission and developing the website of the company.

Publications

• Préparation de carmustine : une alternative à la chlormethine et mechlorethamine : bilan d'activité sur 9 mois de fabrication. Messaouik D, Rodier C, Boyer-Grand A, Jouannet-Romaszko M, Chopineau J. Poster. Hopipharm, 2004
• Compatibility and stability of parenteral analgesic admixtures for multimodal analgesia. D. Balayssac, PharmD, PhD; L. Badaroux, MSc; C. Rodier, PharmD; V. Sautou-Miranda, PharmD, PhD; J.E. Bazin, MD, PhD; J. Chopineau, PharmD, PhD. European Journal of Hospital Pharmacy Science, 2009, vol. 15, no. 4, p. 78-82

Marie is a Project Manager in Regulatory Intelligence and is responsible for managing the IDRAC Eastern EU team which includes Russia and International information. Marie actively participates in the development of new regulatory content to provide comprehensive views on hot regulatory topics arising within the European Union.

Marie has 6 years of experience in Regulatory Affairs. Before joining Thomson Reuters in 2010, she worked as a Regulatory Affairs Specialist in the Pharmaceutical Industry where she was in charge of post-marketing authorization activities, such as Marketing Authorization Application submissions and maintenance in Eastern European countries. She also has experience in pre-marketing authorization activities such as Orphan drug Applications in Europe and Clinical Trial Application filings in European countries. She is used to working in an international environment and coordinates projects within a pharmaceutical company.

Marie is a pharmacist and studied at the University of Rennes I, France. She holds a Master of Science on Health care products derived from biotechnology from Paris XI University, Châtenay-Malabry, France.

Molly Fellin Spence is a medical/regulatory writer for Thomson Reuters. She earned a bachelor's degree in journalism from the College of Communications at the Pennsylvania State University. Ms. Spence is a writer and editor with more than 15 years of professional experience at a number of newspapers and other publications. She worked as the managing editor of The Gazette newspaper for nearly a decade, leading a staff of journalists to provide innovative and enterprising information to readers. Her work has focused on a wide variety of topics, including education, business, finance, and government issues.

DIA Global Forum Articles

• Spotlight on European Regulatory Network PDF | December 2012
• Communicating Drug Information in a Virtual World PDF | April 2012

JCS Articles

• FDA's Pediatric Advisory Committee Achieves 200+ Product Reviews PDF | July 2012
• Early research efforts increase in fight against Alzheimer's epidemic | May 2013

Miriam Bayes joined Thomson Reuters with the acquisition of Prous Science and is now Head of Scientific & Content Development with a team of more than 80 people selecting, analyzing structuring and indexing the content for our databases and on-line clinical platforms as well as producing 5 different journals in the field of Drug R&D. She also acts as project leader of the Biomarkers database.

Her role includes the management of content for Prous Science Integrity, a comprehensive drug discovery and development database providing integrated biological, chemical and pharmacological information to support scientists at the front end of drug research and development.

Miriam graduated as from the Universidad Navarra, was trained in Clinical Pharmacology and obtained her PhD in Medicine from the University of Barcelona where she lectured on clinical pharmacology in pre- and post-graduate programs.

She is a member of European Society of Clinical Pharmacology and has published and presented at congresses on pharmacokinetics, pharmacodynamics and tolerability of drugs in clinical trials.

Product Expertise

• Prous Science Integrity
• BIOMARKERcenter

 

Carolyn Finch is the Biodiscovery Product Specialist responsible for supporting the sales force as they explore the biological information needs of our customers.

Prior to this Carolyn initiated a product knowledge development program for our global sales force where she managed a team of four trainers and provided product knowledge training to employees across the business. The success of the program was recognised with a Gold Award from the Institute of I.T. Training.

Joining us as an editorial patent analyst, Carolyn was responsible for indexing records for DWPI and GENESEQ databases before joining the training and development department where she designed and delivered technical training for our editorial analysts.

She holds a degree in Biology with European Studies from the University of Sussex which included a year in France, working in a Molecular Biology laboratory.

Product Expertise

• BIOMARKERcenter
• BONDplus
• GENESEQ

Colin Williams is the Director of Product Strategy where he is responsible for developing solutions for biologists and those working with this information. Colin has been with us since November 2005, his roles have included editorial operations management and commercial leadership in producing and launching new databases which improve the efficiency of biology based research.

He has a degree in Biochemistry and PhD in X-ray Crystallography entitled "The structure of E. coli Aconitase B" both from the University of Sheffield.

After some brief post doctoral work he moved to ASM Scientific, a start-up biotechnology company in Cambridge, UK. Here, as part of a team of three, he developed a novel isothermal DNA amplification technology for use in point of care pathogen detection winning the 2005 Best Biomedical Research Innovation at the Medical Futures Innovation awards.
Colin has published articles in Nature Structural Biology, Molecular Microbiology and PLoS Biology as well as having a number of granted and published patents and patent applications in the field of DNA amplification.

Product Expertise

• BIOMARKERcenter
• BONDplus
• GENESEQ

Presentations & Conferences

• Sequence Searching | PIUG Biotechnology Conference | 2007 & 2008

Dr. Nikolsky has over ten years of experience in the life sciences industry, in business and research. Prior to joining GeneGo, he was CEO of ChemDiv (San Diego, CA), a medicinal chemistry outsourcing company. Earlier, he co-founded and served as VP of Business Development at Integrated Genomics, Inc. (Chicago, IL), a comparative genomics and bioinformatics company. Dr. Nikolsky has also held positions as a Senior Scientist for Thermogen, Inc. (Chicago, IL) and as Research Associate (Instructor) at the University of Chicago. Dr. Nikolsky holds an MBA degree in Finance from the University of Chicago, a Master's degree in Biology from Moscow State University, and a Doctoral degree in Molecular Genetics from VNII Genetika Graduate School in Moscow, Russia.

Ann Wescott joined Thomson Reuters with the acquisition of Prous Science in 2007. She has been with Prous Science for more than 20 years and participated in the development of all the company's drug R&D databases, starting with diskette and classic online formats in the 1980s and progressing to the Prous Science Integrity drug discovery and development online portal.

Product Expertise

• Prous Science Integrity